The Safety Profile of J&J's CD19/CD20-Targeted CAR-T Therapy JNJ-90014496 in R/R LBCL

Matthew Ku, MBBS, FRACP, RACP, FRCPA/RCPA, PhD
(image credit: Epworth)

Data from a phase 1b clinical trial (NCT05421663) evaluating Johnson & Johnson’s JNJ-90014496, a CD19 and CD20-directed bispecific chimeric antigen receptor (CAR) T-cell therapy, were presented at the European Hematology Association (EHA) 2025 Congress, held June 12 to 15, both virtually and in Milan, Italy. During the conference, CGTLive®'s sister site, OncLive®, sat down with Matthew Ku, MBBS, FRACP, RACP, FRCPA/RCPA, PhD, an associate professor and the lymphoma stream lead at St Vincent’s Hospital, to discuss the findings.

Ku went over the key safety and efficacy results from the study that were reported at the meeting. He focused on data from the group that received the recommended phase 2 dose, pointing out this group's overall response rate (ORR) of 100%.

OncLive: Can you discuss the safety profile of JNJ-90014496 in this trial?

Matthew Ku, MBBS, FRACP, RACP, FRCPA/RCPA, PhD: The data was divided into those that had all the doses and those that had just the recommended phase 2 dose. So we're just focusing on the recommended phase 2 dose, the 75 million CAR T-cells. It was really well tolerated. The most common treatment-emergent adverse events (AEs) were cytopenias, like neutropenia, as well as cytokine release syndrome (CRS). In terms of the grade 3 or 4 or higher events—for CRS, in the recommended phase 2 dose group, there was no grade 3 or 4 CRS events. In terms of infections, there was only 1 case of grade 3 or 4 infection events in the recommended phase 2 dose group. So it's really well-tolerated. Overall, only 7 patients, or 28% of the recommended phase 2 dose group, reported a serious treatment emergent AE.

There were 6 deaths on the study out of 51 patients altogether. All 6 deaths were due to disease progression, none of which were due to the therapy delivered.

What were the efficacy data like?

Again, the data is presented for all of the patients, as well as for the recommended phase 2 dose. So just focusing on the recommended phase 2 dose, if we look at patients that had only 1 prior line of therapy (so those that are older and not transplant eligible) their ORR was 100% and their complete remission (CR) rate was 80%.

In patients that had 2 or more prior lines of therapy, the ORR was still above 90%. There was a CR rate around about 75%. So we can see that in the recommended phase 2 dose group, irrespective of how many lines the patients have had, the response rate is very high, especially the CR rate. It's very encouraging so far.

This transcript has been edited for clarity.

Click here to view more coverage of EHA's 2025 Congress.